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OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN)

Primary Purpose

The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY )

About this trial

This is an interventional other trial for The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients focused on measuring RADIATION-RELATED OPTIC NEUROPATHY,NASOPHARYNGEAL CARCİNOMA, RADIOTHERAPY

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient with nasopharyngeal carcinoma that histopathologically confirmed Age >18 Radiotherapy or chemoradiotherapy applied to the patient in our clinic No recurrence or metastasis during follow-up Optic evaluation Evaluation with MRI or CT during follow-up

Exclusion Criteria:

Cranial RT No histopathological verification Age< 18 There were locoregional recurrence or metastasis

Sites / Locations

Meltem DağdelenRecruiting

Outcomes

Primary Outcome Measures

OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN) RADIATION-RELATED OPTIC NEUROPATHY

RADIATION-RELATED OPTIC NEUROPATHY

Secondary Outcome Measures

Full Information

NCT ID

NCT04724590

First Posted

January 21, 2021

Last Updated

January 21, 2021

Sponsor

Istanbul University - Cerrahpasa (IUC)

1. Study Identification

Unique Protocol Identification Number

NCT04724590

Brief Title

OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA

Acronym

ORONIN

Official Title

OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA (ORONIN)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 3, 2020 (Actual)

Primary Completion Date

April 3, 2021 (Anticipated)

Study Completion Date

May 3, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Primary treatment in nasopharynx cancers is radiotherapy (RT) or chemoradiotherapy (CRT) depending on the stage of the tumor. According to the guidelines, the dose of radiotherapy for primary tumors varies between 66-70 Gy. In consideration of modern radiotherapy techniques like IMRT with systemic chemotherapy for nasopharyngeal cancer, loco-regional control has been perfect. However, the rate of late complications from treatment, many of which are irreversible, is still high. Radiation-related optic neuropathy is the late complication that optic nerves might be affected during the radiotherapy due to the close location of the nasopharynx. Incidence of this is 8.7-9% in head and neck cancer and is observed between 2-9 years after RT. Painless, irreversible, and progressive vision loss usually occurs, and the pallor of optic disc margins, retinal vein dilatation, bleeding, and neovascularization are in the ophthalmic examination. The risk of optic neuropathy increases when the tumor is in close contact with optic nerves, radiation dose, concurrent chemotherapy used, history of diabetes or hypertension. The aim of our study is to prospectively evaluate optic neuropathy in nasopharynx cancer patients treated in our clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

The Aim of Our Study is to Prospectively Evaluate the Optic Neuropathy in Nasopharynx Cancer Patients

Keywords

RADIATION-RELATED OPTIC NEUROPATHY,NASOPHARYNGEAL CARCİNOMA, RADIOTHERAPY

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Radiation

Intervention Name(s)

IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY )

Other Intervention Name(s)

OCT(Optical Coherence Tomography), OCT-A(Optical Coherence Tomography Angiography)

Intervention Description

Evaluation the optic neuropathy in nasopharynx cancer patients treated in our clinic.

Primary Outcome Measure Information:

Title

Description

RADIATION-RELATED OPTIC NEUROPATHY

Time Frame

2-9 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with nasopharyngeal carcinoma that histopathologically confirmed Age >18 Radiotherapy or chemoradiotherapy applied to the patient in our clinic No recurrence or metastasis during follow-up Optic evaluation Evaluation with MRI or CT during follow-up Exclusion Criteria: Cranial RT No histopathological verification Age< 18 There were locoregional recurrence or metastasis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Meltem Dağdelen, MD

Phone

+905426603810

meltemdagdelen@windowslive.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ceren Barlas, MD

Phone

+905052757730

dr.cicibiyik@gmail.com

Facility Information:

Facility Name

Meltem Dağdelen

City

Istanbul

ZIP/Postal Code

34096

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meltem Dağdelen, MD

Phone

+905426603810

meltemdagdelen@windowslive.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

OPHTHALMOLOGIC EVALUATION OF RADIATION-RELATED OPTIC NEUROPATHY FOLLOWING IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY (IMRT) FOR NASOPHARYNGEAL CARCİNOMA

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